{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "189357",
      "product_res_number": "Z-0172-2022",
      "event_date_initiated": "2021-09-02",
      "event_date_created": "2021-10-22",
      "recall_status": "Open, Classified",
      "res_event_number": "88683",
      "product_code": "MLV",
      "pma_numbers": [
        "P050006S044"
      ],
      "product_description": "REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948\n*Not distributed within the US",
      "code_info": "serial numbers 22689696 through  23569078",
      "firm_fei_number": "2017233",
      "recalling_firm": "W L Gore & Associates, Inc.",
      "address_1": "3750 W Kiltie Ln",
      "city": "Flagstaff",
      "state": "AZ",
      "postal_code": "86005-8712",
      "additional_info_contact": "Gore Customer Service\n800-528-8763",
      "reason_for_recall": "Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.",
      "root_cause_description": "Software change control",
      "action": "Gore initiated distribution of \"Urgent Medical Device Recall\" Notification to affected consignees between the dates of September 2, 2021 - September 21, 2021. The customer communication was distributed via Email and UPS. In addition, to informing consignees about the recall, Gore asked consignees to take the following actions:\n\n1. Identify and return any unused devices within the scope of this voluntary recall.\nReturn Authorization number can be found on the CUSTOMER RESPONSE FORM.\n\n2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to\nWLGore3120@sedgwick.com within 3 weeks of receipt of this notification.\n\n3. Please share this letter with others in your hospital or clinic as appropriate.\n\n4. If a listed device has been used, there is no patient-follow up needed and there are\nno further actions needed other than informing Gore the device was used. Please\nindicate the used devices on the CUSTOMER RESPONSE FORM and return to\nWLGore3120@sedgwick.com within 3 weeks of receipt of this letter. No further\naction is needed.\n\n5. Please contact your local Gore field sales associate with any questions regarding this notice, and to coordinate the return and replacement of any unused affected devices. Additionally, you may also contact Gore Customer Service (Email: MPDCustomerCare@wlgore.com; or by phone (U.S. toll free: (800) 528-8763)).\n\n6. In the event that an adverse event occurs:\nAny adverse event involving the GORE CARDIOFORM Septal Occluder should be\nreported to the manufacturer and the country specific regulatory authorities immediately. To report an event to W. L. Gore & Associates, email: medcomplaints@wlgore.com\nor contact: USA: 800 528 1866 Ext. 44922 / 928 864 4922, Fax 928 864 4364\n\nHealthcare professionals and consumers may report adverse events or quality\nproblems directly to FDA using the FDA MedWatch Website:\nhttps://www.accessdata.fda.gov/scripts/medwatch/index.cfm",
      "product_quantity": "15 units",
      "distribution_pattern": "US:  AL,AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,MO,MS,MT,NC, ND, NE, NH, NJ, NM,NV,NY,OH,OK,OR,PA,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV\n\nOUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE",
      "openfda": {
        "device_name": "Transcatheter Septal Occluder",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P000039",
          "P120021",
          "P050006",
          "P000049",
          "P040040"
        ],
        "registration_number": [
          "3005704822",
          "3010273872",
          "2135147",
          "3007113487",
          "3014918977",
          "3012179728",
          "1928237",
          "1721676",
          "2183744",
          "2011171",
          "2017233"
        ],
        "fei_number": [
          "3005704822",
          "3010273872",
          "3007113487",
          "3014918977",
          "3012179728",
          "3005334138",
          "1928237",
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        ]
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}